Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
49441–49464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 2010
ISOLED AC-POWERED LED HEADLIGHT SYSTEM
K102266 · FST
Isolux, LLC
General & Plastic Surgery · 45d
Cleared Sep 24, 2010
GMK REVISION KNEE SYSTEM
K102437 · JWH
Medacta International S.A.
Orthopedic · 29d
Cleared Sep 23, 2010
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE
K091561 · MKJ
ZOLL Medical Corporation
Cardiovascular · 483d
Cleared Sep 23, 2010
ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD
K100037 · MAX
Advanced Vertebral Solutions, LLC
Orthopedic · 260d
Cleared Sep 23, 2010
ASCENT F-COAT MODEL: 006-00097
K100540 · LBH
CAO Group, Inc.
Dental · 210d
Cleared Sep 23, 2010
GUIDE CATHETERS AND ACCESSORIES
K101015 · DQY
Thomas Medical Products, Inc.
Cardiovascular · 164d
Cleared Sep 23, 2010
ACCUSCULPT II LASER SYSTEM
K101573 · GEX
Lutronic Corporation
General & Plastic Surgery · 108d
Cleared Sep 23, 2010
AFFIRM DO DIODE LASER
K101601 · GEX
Cynosure, Inc.
General & Plastic Surgery · 107d
Cleared Sep 23, 2010
NEOWIRE PTA/PTCA GUIDEWIRE
K101729 · DQX
Neometrics, Inc.
Cardiovascular · 94d
Cleared Sep 23, 2010
ROSA SURGICAL DEVICE
K101791 · HAW
Medtech S.A.S
Neurology · 87d
Cleared Sep 23, 2010
NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
K102018 · GXP
Synthes USA Products, LLC
Neurology · 66d
Cleared Sep 22, 2010
ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S
K100578 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 205d
Cleared Sep 22, 2010
UROSTATION 3D PROSTATE SUITE
K100793 · LLZ
Koelis
Radiology · 184d
Cleared Sep 22, 2010
CALGAESEAL MODEL: CAS
K101097 · QSY
Bz Medical, Inc.
General & Plastic Surgery · 155d
Cleared Sep 22, 2010
ENSITE VERISMO SEGMENTATION TOOL V.2.0
K101697 · LLZ
St Jude Medical
Radiology · 98d
Cleared Sep 21, 2010
PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K100479 · NDN
Arthrocare Corp.
Orthopedic · 215d
Cleared Sep 21, 2010
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
K100845 · NKB
Zimmer Spine, Inc.
Orthopedic · 180d
Cleared Sep 21, 2010
EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL...
K101761 · LPH
Exactech, Inc.
Orthopedic · 90d
Cleared Sep 21, 2010
CRITICAL CARE ASSESSMENT
K101983 · JOM
Critical Patient Care, Inc.
Cardiovascular · 69d
Cleared Sep 21, 2010
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K102462 · MED
STERIS Corporation
General Hospital · 25d
Cleared Sep 20, 2010
E-LIGHT LINE
K092734 · GEX
Espansione Marketing S.P.A
General & Plastic Surgery · 381d
Cleared Sep 20, 2010
GERATHERM UNIQUERESC
K093694 · DWJ
Geratherm Medical AG
Cardiovascular · 294d
Cleared Sep 20, 2010
AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL...
K093883 · CIT
Seppim S.A.S.
Chemistry · 276d
Cleared Sep 20, 2010
WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B,...
K100969 · JOW
Wmi Enterprises, LLC
Cardiovascular · 165d